Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction
Status: Completed
Location: See all (110) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study assesses the 18-month incidence of inappropriate shocks in subjects implanted with the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) for primary prevention of sudden cardiac death. Devices are to be programmed with zone cutoffs at 200 bpm and 250 bmp in order to mimic the programming settings for transvenous ICDs in the MADIT RIT study. The incidence of inappropriate S-ICD shocks will be compared to the incidence of inappropriate shocks observed in the MADIT RIT study.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: No
View:
• Patient with ischemic or non-ischemic heart disease who meets current guidelines for ICD therapy and intends to undergo a de novo implant procedure for an EMBLEM™ S-ICD (or newer generation BSC S-ICD)
• Left ventricular ejection fraction ≤ 35%
• A passing EMBLEM™ S-ICD (or newer generation BSC S-ICD) screening ECG
• Patient ≥ 21 years of age willing and capable of giving informed consent
• Patient willing and capable of complying with follow-up visits
Locations
United States
Alabama
Alabama Cardiovascular Group
Birmingham
Huntsville Hospital - The Heart Center, PC
Huntsville
Arizona
Mercy Gilbert Medical Center
Gilbert
Mayo Clinic Phoenix
Phoenix
California
Glendale Adventist Medical Center
Glendale
Sharp Grossmont Hospital
La Mesa
University of Southern California Hospital
Los Angeles
Alta Bates Medical Center
Oakland
St. Joseph Hospital
Orange
Good Samaritan Hospital - San Jose
San Jose
Harbor UCLA Medical Center
Torrance
Connecticut
Yale University School of Medicine
New Haven
Delaware
Cardiology Physicians PA
Newark
Florida
Baptist Medical Center
Jacksonville
Florida Hospital
Orlando
Tallahassee Memorial Hospital
Tallahassee
Georgia
Emory University Hospital
Atlanta
University Hospital
Augusta
Iowa
University of Iowa Hospitals and Clinics
Iowa City
Illinois
CorVita Science Foundation
Chicago
Northwestern Memorial Hospital
Chicago
University of Chicago
Chicago
Indiana
Northern Indiana Research Alliance - Lutheran Hospital
Fort Wayne
Methodist Hospital of Indianapolis
Indianapolis
St. Vincent's Hospital
Indianapolis
Kansas
Heartland Cardiology
Wichita
Louisiana
Ochsner Clinic Foundation
New Orleans
Advanced Cardiovascular Specialists
Shreveport
Maryland
Peninsula Cardiology Associates
Salisbury
Michigan
St. Joseph Mercy Hospital
Ann Arbor
CardioVascular Institute of Michigan P.C.
Roseville
William Beaumont Hospital
Royal Oak
Minnesota
Centracare Heart and Vascular Center
Saint Cloud
HealthEast St. Joseph's Hospital
Saint Paul
Missouri
Cox Health
Springfield
Mercy Research
Springfield
Mississippi
North Mississippi Medical Center
Tupelo
North Carolina
Memorial Mission Hospital
Asheville
University of North Carolina Hospital
Chapel Hill
Durham VA Medical Center
Durham
Rex Hospital
Raleigh
Nebraska
The Nebraska Medical Center
Omaha
New Jersey
Deborah Heart and Lung Center
Browns Mills
Cooper Hospital - University Medical Center
Camden
Cardiovascular Associates of the Delaware Valley
Sewell
Nevada
HealthCare Partners Cardiology
Las Vegas
New York
Albany Medical Center
Albany
Northwell Health
New Hyde Park
Beth Israel Medical Center
New York
Strong Memorial Hospital of the University of Rochester
Rochester
Ohio
Aultman Hospital
Canton
Ohio State University Medical Center
Columbus
The Toledo Hospital
Toledo
Genesis Healthcare System
Zanesville
Oregon
Salem Hospital
Salem
Sacred Heart Medical Center at Riverbend
Springfield
Pennsylvania
Abington Memorial Hospital
Abington
University of Pittsburgh Medical Center
Pittsburgh
South Carolina
AnMed Health
Anderson
Medical University of South Carolina
Charleston
Texas
South Texas Veterans Health Care System
San Antonio
Trinity Mother Frances Health System
Tyler
Utah
University of Utah Hospital and Clinics
Salt Lake City
Virginia
Centra Stroobants Cardiovascular Center
Lynchburg
Sentara Norfolk General Hospital
Norfolk
Virginia Commonwealth University Health System
Richmond
Washington
Evergreen Hospital Medical Center
Kirkland
CHI Franciscan Health System
Tacoma
Wisconsin
St. Mary's Madison
Madison
Other Locations
Belgium
Clinique Saint-Jean
Brussels
Universitair Ziekenhuis Gent
Gent
Canada
Institut universitaire de Cardiologie et de Pneumologie de Quebec
Ste-foy
Denmark
University Hospital
Odense
France
CH Annecy
Annecy
CHU Dijon
Dijon
CHRU de Lille
Lille
CHU La Timone Hospital
Marseille
CHU Montpellier
Montpellier
Hospital de la Pitie-Salpetriere
Paris
CHRU Hopital Pontchaillou
Rennes
Nouvel Hôpital Civil De Strasbourg
Strasbourg
Clinique Pasteur
Toulouse
CHRU Nancy Brabois
Vandoeuvre Les Nancy
Germany
Deutsches Herzzentrum Berlin
Berlin
Unfallkrankenhaus Berlin Marzahn
Berlin
University Hospital Frankfurt
Frankfurt
Universitaetsmedizin Greifswald
Greifswald
Universitaetsklinik Eppendorf
Hamburg
Universitaetsklinikum Heidelberg
Heidelberg
University Hospital of Muenster
Muenster
Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo
Azienda Ospedaliero Universitaria Pisana
Pisa
Azienda Ospedaliera Universitaria Integrata di Verona
Verona
Netherlands
Academisch Medisch Centrum
Amsterdam
St. Antonius Ziekenhuis
Nieuwegein
Erasmus MC - University Medical Center Rotterdam
Rotterdam
Poland
Centralny Szpital Kliniczny Uniwerytetu Medycznego
Lodz
Puerto Rico
Hospital San Lucas
Ponce
Spain
Hospital Clinico San Carlos
Madrid
Hospital Virgen De La Salud
Toledo
Hospital Miguel Servet
Zaragoza
Switzerland
Cardiocentro Ticino
Lugano
University Hospital Zurich
Zuerich
United Kingdom
Blackpool Victoria NHS Trust Direct
Blackpool
Russels Hall Hospital
Dudley
Glenfield Hospital
Leicester
Cardiothoracic Centre
Liverpool
St. Bartholomews Hospital
London
Northern General Hospital
Sheffield
Southampton University Hospital
Southampton
Time Frame
Start Date: June 9, 2015
Completion Date: December 6, 2019
Participants
Target number of participants: 1173
Treatments
Experimental: Single Arm
Subjects implanted with an EMBLEM S-ICD with rate zones set at 200 bpm and 250 bpm per protocol.
Authors
Venkata Sagi, Farhat Khairallah, Fausto Devecchi, Matthew Smelley, Erik Altman, Brian Sarter, Richard Kuk, Anil Rajendra, Marcie Berger, Samir Saba, Alborz Hassankhani, David Huang, Johan Aasbo, Steven Rowe, Karl Crossen, Anil Gehi, Luis Scott, Raul Weiss, John Schutzman, Marc Girsky, Ira Friedlander, John Schoenhard, Ali Shakir, Taral Patel, Patrick Aquilina, Drory Tendler, John Mckenzie, Abdulhay Albirini, Shane Tsai, J. Lacy Sturdivant, Michael Gold, Jay Dinerman, Gaurav Upadhyay, Matthew Fedor, Radmira Greenstein, Rick Henderson, Edward Kim, Sanjay Bindra, Daniel Morin, Sameh Mobarek, Albert Sun, Niuton Koide, Miguel Valderrabano, Roger Freedman, Martin Burke, Bradley Knight, Emmanuel Nsah, Sherman Wiggins, Pedram Kazemian, Brian Kim, Kelly McDonnell, Michael Shehata, Faisal Merchant, Firas Hamdan, Jason Chinitz, Rahul Doshi, Matthew Trojan, Deepak Bhakta, Jude Clancy, Andrew Zadeh, Charles Gottlieb, Gregory Granrud, Santosh Varkey, Nathan Segerson, Francisco Perez-Gil, Manoj Panday, Rizwan Alimohammad, Troy Rhodes, Shang-Chiun Lee, Stanislav Weiner, Hazim Al-Ameri, Robert Lewis, Magdy Migeed, Geraldine Bertaux, G. Andre Ng, Serge Boveda, Corinna Lenz, Hugues Blangy, Lars Eckardt, Nigel Lewis, Nicolas Badenco, Paul Roberts, Michel Chauvin, Edgar Zitron, Nils Gosau, Christelle Marquie, Pierre Mondoly, Mathias Busch, Didier Irles, Franck Molin, Michael Lee, Naushad Shaik, Liesbeth Timmers, Margaret Hood, Craig Barr, Stefano Viani, Gautham Kalahasty, Paolo De Filippo, Pawel Ptaszynski, Jan Steffel, Reinoud Knops, Pier Lambiase, Lucas Boersma, George Mark, Giovanni Morani, David Wright, Prashant Bhave, Eugene Chung, Calvo Naiaria, Christophe Leclerq, Ghiyath Tabbal, Nicasio Perez Castellano, Calvo Naiara, Jean-Claude Deharo, Dominic Theuns, Leonardo Calo, Jean-Luc Pasquie, Clemens Steinwender, Stefan Hohnloser, Miguel Angel Arias, Christoph Klein, Sam Hanon, Tiziano Moccetti, Jean Frederic
Related Therapeutic Areas
Sponsors
Leads: Boston Scientific Corporation